FDA UDI In Commercial Distribution 🇺🇸 United States

Diego

DI: 00821925037809 · Model: 70236100 · Gyrus Acmi, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Diego
Primary DI
00821925037809
Version / Model
70236100
Company Name
Gyrus Acmi, Inc.
Labeler DUNS
007198742
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-12
Public Version
2
Public Version Date
2023-09-18
Public Version Status
Update
Public Device Record Key
8cc15aab-2ebd-4c5c-9b09-a75c72cbe489

Device Description

DIEGO POWERED DISSECTOR DIAMOND BULLET BURR IRRIGATING, 3 MM DIAMETER STRAIGHT

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
EQJ BUR, EAR, NOSE AND THROAT

GMDN Terms

Code Name
45527 Diamond ENT bur, single-use

Identifiers

Type ID
Package 00821925026001
Primary 00821925037809